Few drugs have taken the market by storm like Xarelto. Developed as an improvement over Coumadin; the ‘standard’ of blood thinning medications since the 1960s, Xarelto has seen billions of dollars in sales growth since its release in 2011. In fact, Xarelto sales more than doubled in the four-year span between 2013 and 2016, topping out at $3.2 billion in 2016. This makes it Bayer’s top-selling medication.
On the surface, these numbers would appear stellar. Look a little deeper, however, and the story surrounding Xarelto rapidly comes crashing back to Earth.
As of this writing, more than 18,000 lawsuits are pending against Bayer AG and Johnson & Johnson over allegations that Xarelto causes uncontrollable and, perhaps more alarmingly, unstoppable internal bleeding in some patients. Based on reports filed with the FDA, these Xarelto bleeds could be responsible for at least 370 deaths.
A recent story posted to Bloomberg details the circumstances surrounding the first of these Xarelto bleeding lawsuits to go to trial. A New Orleans jury heard the story of Joseph Boudreaux, a part-time security guard who started taking Xarelto to cut his risk of stroke. Instead, he spent a week in the ICU and endured multiple blood transfusions and heart procedures to keep him alive. He equates the decision to start Xarelto as one of the biggest mistakes of his life. “I don’t want anybody else to suffer like I have from that drug,” he says.
Xarelto lawsuits are based on the accusation that Johnson & Johnson and Bayer falsely marketed the drug. It is said to be easier to use that Coumadin and requires no blood tests like those that are required for other blood thinners.
Those tests could be used to determine whether a patient is at a higher risk of developing Xarelto-related side effects. Add in the fact that there is no antidote to Xarelto and what you have is a formula for disaster. Putting it simply, once Xarelto goes to work thinning a patient’s blood there is no way to stop it.
Skipping critical steps in the care of a patient – things like proper testing and ensuring that emergency safety measures can be implemented if necessary – don’t make a drug “easier to use.” Rather, they are the implementation of dangerous series of shortcuts that have cost hundreds of people their lives.
This week, the bellwether trial ended with a verdict for J&J and Bayer. A spokesperson for one of the defendants, William Foster, told Fierce Pharma “the decision ‘reflects the facts of this case and the appropriateness’ of Xarelto’s prescribing information.” Thousands of plaintiffs will now await the next trial to see if the next set of jurors agrees with Mr. Foster in upcoming cases.